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Executive Director, Site Start Up & Regulatory
INC Research
Place of work
Bratislava, Any INC Office, GB-SRY
Bratislava, Any INC Office, GB-SRY
Contract type
full-time
full-time
Information about the position
Job description, responsibilities and duties
INC Research employees don’t accept ordinary. From therapeutic experts to administrative support staff, each member of our 5,000-strong team continually searches for better. Whether that’s better clinical development through our unique Trusted Process®, or better insights from the 100-plus countries in which we operate. It means we deliver success faster, not only for our customers and the patients we serve, but also ourselves.
We are currently seeking an Executive Director, Site Start Up & Regulatory for our FSP Business Unit which is dedicated to one sponsor.
The position has become available due to promotion.
This global Business Unit works across a number of therapeutic areas and is a true partnership with the sponsor.
This partnership was ranked as 2nd in Top 5 Strategic CRO/Pharma Partnerships in 2012.
The FSP Business Unit includes Feasibility, Country and Site Start Up, Site Contracts, Site Management, Global Data Sciences and TMF.
Core Responsibilities:
-Responsible and accountable for the effective management of the operational and financial activities of the Site Start-Up & Regulatory function globally for the FSP Business Unit.
-Directs the development and implementation of the Site Start-Up services delivered under area of responsibility.
-Builds strategic relationships with the sponsor including ensuring fulfillment of customer requirements.
-Ensures continuous improvement of quality in all SSU components at the project level (submissions, essential document collection, communication to Competent Authority, Ethics Committees, etc).
-Performs strategic and operational level planning, including efficient allocation of resources within the department and/or business unit.
-Functional P/L responsibility for all projects and strategic programs within the assigned departments and/or business unit.
We are currently seeking an Executive Director, Site Start Up & Regulatory for our FSP Business Unit which is dedicated to one sponsor.
The position has become available due to promotion.
This global Business Unit works across a number of therapeutic areas and is a true partnership with the sponsor.
This partnership was ranked as 2nd in Top 5 Strategic CRO/Pharma Partnerships in 2012.
The FSP Business Unit includes Feasibility, Country and Site Start Up, Site Contracts, Site Management, Global Data Sciences and TMF.
Core Responsibilities:
-Responsible and accountable for the effective management of the operational and financial activities of the Site Start-Up & Regulatory function globally for the FSP Business Unit.
-Directs the development and implementation of the Site Start-Up services delivered under area of responsibility.
-Builds strategic relationships with the sponsor including ensuring fulfillment of customer requirements.
-Ensures continuous improvement of quality in all SSU components at the project level (submissions, essential document collection, communication to Competent Authority, Ethics Committees, etc).
-Performs strategic and operational level planning, including efficient allocation of resources within the department and/or business unit.
-Functional P/L responsibility for all projects and strategic programs within the assigned departments and/or business unit.
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Postgraduate (Doctorate)
Postgraduate (Doctorate)
Educational Specialization
Pharmacy, Clinical Research Studies, Regulatory
Language skills
English - Upper intermediate (B2)
Personality requirements and skills
-Extensive Clinical Trial experience including global Site Start Up experience at a senior level.
-Significant experience managing teams of clinical research staff.
-Thorough knowledge of clinical research management processes.
-Strong understanding of the needs of countries and the ability to work across geographic regions.
-Strong CRO operational experience with a track record in project management working in an international or global capacity. .
-Significant experience managing teams of clinical research staff.
-Thorough knowledge of clinical research management processes.
-Strong understanding of the needs of countries and the ability to work across geographic regions.
-Strong CRO operational experience with a track record in project management working in an international or global capacity. .
Advertiser
Brief description of the company
Why INC Research:
We provide competitive salaries, comprehensive benefits packages and the support and training available from working with a top ranking and award winning CRO.
As one of the fastest-growing global providers of Phase I-IV services we offer experience spanning the globe, along with retention capabilities and broad therapeutic expertise, to meet our customers' clinical development challenges.
INC Research offers endless opportunities to take your career in the direction you want. – Just follow your ambition.
INC Research rated the “Top CRO” in the 2013 CenterWatch Global Investigative Site Relationship Survey .
We provide competitive salaries, comprehensive benefits packages and the support and training available from working with a top ranking and award winning CRO.
As one of the fastest-growing global providers of Phase I-IV services we offer experience spanning the globe, along with retention capabilities and broad therapeutic expertise, to meet our customers' clinical development challenges.
INC Research offers endless opportunities to take your career in the direction you want. – Just follow your ambition.
INC Research rated the “Top CRO” in the 2013 CenterWatch Global Investigative Site Relationship Survey .
ID: 1791725
Dátum zverejnenia: 4.7.2014
2014-07-04
lokalita: Bratislava Pozícia: Chief Executive Officer, Regulatory Affairs Manager, Regulatory Affairs Specialist Spoločnosť: INC Research